Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes
研究概览
简要总结
The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.
详细描述
Metabolic synergy exists between choline, phospholipid, and polyunsaturated fatty acid metabolism. Previous evidence from our laboratory has shown that higher dietary choline intakes increase the amount of docosahexaenoic acid (DHA) incorporated into phosphatidylcholine (PC), as measured by PC-DHA concentrations in circulating erythrocytes. PC-DHA results from the production of PC through the phosphatidyl N-ethanolamine methyltransferase (PEMT) pathway and is critical for exporting fat from the liver to peripheral tissues. We are expanding this work to pregnant women, for whom DHA intake is critical to support the developing infant's growth, by undertaking a double blind, randomized controlled trial of choline supplementation (500mg) throughout the 2nd and 3rd trimesters of pregnancy. All women will consume 200mg of docosahexaenoic acid (DHA), a prenatal vitamin, and 25-50mg of deuterated choline (choline d9) daily throughout the duration of the trial. The use of a stable isotope will allow for modeling of choline dynamics throughout the 2nd and 3rd trimester of pregnancy, and calculate the activity of PEMT in pregnant women. Consenting participants will provide a baseline blood draw, followed by 2 additional blood draws throughout their pregnancies, and maternal/cord blood at birth, in addition to the placenta. This trial will test the hypothesis that choline supplementation increases the amount of PC-DHA in the blood of pregnant women and increase its supply to the developing fetus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All investigators interacting with participants will be masked to the study arm assignment. Only the Primary Investigator and Laboratory Manager (prepares supplements) will have access to participant's study assignment.
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy, singleton pregnant women gestational weeks 12-16, ages 21-40, willingness to comply with the study protocol
排除标准
- •Habitually high choline/DHA intake
- •Pre-pregnancy BMI >32
- •Pregnancy complications and comorbidities (at baseline and throughout the study)
- •Current smokers, drinkers, or drug users
结局指标
主要结局
DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes
时间窗: Gestational Weeks 12-16 through Gestational Weeks 38-41
Phosphatidylcholine species contain 2 fatty acid tails; phosphatidylcholines containing DHA at either the sn-1 or sn-2 positions are found circulating in erythrocytes and serve as a long term marker of DHA status. Erythrocyte PC-DHA is partially supplied by albumin bound lysophosphatidylcholine enriched with DHA, a product of the phosphatidylethanolamine methyltransferase pathway in the liver, which has been shown to be sensitive to dietary choline intakes in non-pregnant women.
次要结局
- The Association of Maternal Choline Supplementation with Infant Recall Memory Score(13 months of age)
- The Association of Maternal Choline Supplementation with Infant Sustained Focused Attention Score(5, 7, 10, and 13 months of age)
- The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments(Gestational Weeks 12-16 through Gestational Weeks 38-41)
- Circulating labeled and unlabeled choline metabolites in maternal plasma(Gestational Weeks 12-16 through Gestational Weeks 38-41)
- The Association of Maternal Choline Supplementation with Infant Visual Recognition Memory Novelty Score(5, 7, 10, and 13 months of age)
- The Association of Maternal Choline Supplementation with Infant Visual Attention Orienting Speed Score(5, 7, 10, and 13 months of age)